Natrecor Criticized by Cardiologist

Cardiologist Eric Topol has written a scathing article about
Natrecor
(nesiritide) in The New England Journal of Medicine (NEJM).
Natrecor is a heart-failure drug that has been shown to decrease
shortness of breath.

In his article, Dr. Topol cites US Food and Drug Administration
(FDA) data that support concerns about possible kidney damage
associated with Natrecor use, going so far as to suggest that
Natrecor should not be on the market.

“In my view, nesiritide [Natrecor] has not yet met the
minimal criteria for safety and efficacy,” says Dr. Topol,
chairman of cardiology at the Cleveland Clinic. “Until a
trial definitively proves that this drug reduces the risk of death
or repeated hospitalization for heart failure, there will be
questions about the appropriateness of the drug’s use or even
commercial availability.”

One main concern is that Natrecor, which received FDA approval
only for limited use in a hospital setting, is now being prescribed
by doctors for many patients, even outside the hospital. Topol also
points out that prescribing Natrecor is potentially lucrative for
physicians, writing:

“How can a drug that is associated with higher rates of
renal dysfunction and death than placebo — and that costs 50
times as much as standard therapies and for which there are no
meaningful data on relevant clinical end points — be given to
more than 600,000 patients and be promoted…for serial
outpatient use, an indication not listed on the label?”

In the NEJM article, Topol cites data from a 2001 study
of Natrecor that show a mortality increase for Natrecor patients
that may have been caused by chance, and increases in kidney
chemicals that were statistically significant. A researcher on this
study, Wilson S. Colucci of Boston University, says the data were
collected at 5 days, and not 30, as Topol states, and their
relevance remains questionable, according to a Forbes.com article
published 13 July.

Natrecor is manufactured by Johnson & Johnson (J&J).
Mark Wolfe, a J&J spokesman, commented in the Forbes.com
article, "While we agree that survival would be the most meaningful
benefit, no medicine for acute decompensated heart failure has been
demonstrated to provide a survival benefit.

“Natrecor is the only approved treatment that has
demonstrated proven clinical benefit." (Clinical studies show
Natrecor decreases shortness of breath.)

In June 2005, J&J convened a panel of cardiologists, who
recommended strict limits to prescribing Natrecor, including
tighter FDA label-warnings. The panel also recommended urgently
undertaking a substantial clinical trial to measure
Natrecor’s ability to extend patients’ life, and to
test whether it causes kidney damage.

Despite these concerns, J&J continues to market Natrecor,
even providing a hotline for doctors to help them arrange
reimbursement for Natrecor by insurance companies. According to the
Forbes.com report, this hotline still provides information about
obtaining reimbursement from Medicare or insurance companies for
non–FDA-approved uses of Natrecor.

Dr. Topol was an outspoken critic of arthritis drugs Vioxx (rofecoxib) and
Bextra (valdecoxib),
both of which have since been taken off the US market.